Are Stronger Dietary Supplement Regulations on the Horizon?

Recently, the Federal Food and Drug Administration (FDA) announced it will hold a full-day public meeting to discuss strategies for responsible innovation in the dietary supplement industry. The meeting will be held May 16, 2019, from 8:30 a.m. EST to 4 p.m. EST at the FDA Center for Food Safety and Applied Nutrition, Wiley Auditorium, located at 5001 Campus Dr., College Park, MD 20740.

FDA is holding the meeting as part of its effort to strengthen regulation of dietary supplements by modernizing and reforming its oversight activities. FDA has invited interested persons to present ideas related to the following topics:

The scope of the phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” as used to define a dietary supplement in the Dietary Supplement Health and Education Act (DSHEA);

Understanding exceptions to the new dietary ingredient (NDI) premarket notification requirement, and evaluating whether and how growth in the dietary supplement industry has altered the requirement;

Potential commercial or marketing advantages to incentivize responsible innovation; and

As background, DSHEA clarified that FDA primarily regulates dietary supplements as foods that are not subject to FDA’s general premarket requirements. However, DSHEA also imposed certain dietary supplement-specific adulteration and misbranding provisions. The provisions obligate dietary supplement manufacturers to comply with FDA’s current good manufacturing practices, regulations governing statements and claims made on dietary supplement labeling, and FDA’s new drug ingredient (NDI) premarket notification requirements in specific circumstances.

While it remains unclear what regulatory changes FDA could pursue, a February 2019 press release from FDA indicated at least one goal is to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”[1] In this regard, FDA’s regulatory goals could include updates to recall procedures and requirements, increased enforcement against dietary supplements containing NDIs or unapproved drug products, and possibly changing what types of products qualify as dietary supplements.[2] Further, FDA could similarly impose additional premarket notification procedures on dietary supplements or change what types of statements or claims may be made in relation to dietary supplements.

FDA’s public meeting will likely provide industry stakeholders with a clearer picture of what regulatory measures FDA could take concerning dietary supplements. Stakeholders could further benefit by submitting comments and additional information to FDA that support the stakeholder’s particular interests in the dietary supplement industry.

[1] United States Department of Health and Human Services, Food and Drug Administration, Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight, Press Release (February 11, 2019).

Bryan focuses his practice on health care law and provides legal counsel to health care industry clients on a range of issues, such as specialty and mail-order pharmacy operations, provider networks and reimbursement, regulatory compliance, contract review and preparation and 340B programming. He has experience analyzing pharmaceutical trade issues affected by state and federal regulatory frameworks, including pharmacy practice acts, the anti-Kickback Statute, the Drug Supply Chain Security Act, the Stark Law and the Health Insurance Probability and Accountability Act. ...

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